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The starting point for conducting a risk-based audit is to identify and quantify risks. This allows the organization to focus on the areas with the highest potential impact and ensure that resources are allocated effectively to manage these risks.

The process performance index (Ppk) measures the performance of a process relative to the specification limits, accounting for the mean and variability of the process. It is an indicator of how well the process can produce output within the specification limits.

References:

Montgomery, D.C. (2009). Introduction to Statistical Quality Control. Wiley.

ASQ. (n.d.). Process Performance (Pp, Ppk). Retrieved from

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If a quality engineer discovers a situation where unlabeled finished product could be shipped to customers, the appropriate preventive action is to form a team to error-proof the process. This involves identifying and eliminating the root causes of the issue to prevent recurrence, ensuring that processes are robust and error-free.